A company in northern California developing a test for the early detection of colorectal cancer has received six patents for its product.
Sunnyvale, California-based CellMax Life said Tuesday it was granted the patents for its CMx biomimetic platform, which is designed to detect circulating tumor cells (CTCs) in the blood. It is designed as a CLIA-based test run from a central laboratory and ordered by the physician, and the company anticipates Food and Drug Administration and Medicare approval in the next two to three years.
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The product is designed for a purpose similar to Grail, which is also developing a test for early detection of cancers. However, Padma Sundar, CellMax Life’s vice president of marketing, said in a phone interview that what distinguishes her company’s approach from Grail’s is that CellMax Life uses detection of tumor cells, whereas Grail relies on detection of circulating tumor DNA.
The six patents cover the whole CTC-detection workflow, from the capture of cells present at fewer than five per billion in early-stage cancer to the processes ensuring their intact release and identification by means of advanced imaging techniques that allow their detection in up to 90 percent of samples, the company said. The test is designed to cost less than $200, compared with the cost of up to $2,000 for colonoscopy, Sundar said. While the company said the cost is covered entirely by patients, she added that the company is in initial stages of pursuing reimbursement from Medicare and commercial payers.
Data presented at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium in San Francisco on 620 subjects found that the CMx test had a sensitivity of 87 percent for the detection of cancer and a 77 percent sensitivity for the detection of pre-cancerous lesions. Meanwhile, an abstract from Grail’s CCGA study on 1,627 samples – 749 controls and 878 participants with untreated cancers across 20 types – showed 66 percent sensitivity for colorectal cancer.
CellMax Life raised $9 million in a Series A-1 financing round announced July 26, 2016, led by venture capital firm Artiman and several venture capitalists from Taiwan, including Acer founder Stan Shih. Currently, the company is in the process of raising a $50 million Series C round.
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The CMx platform originated from research on biomimetic smart materials and interfaces from Stanford University and is designed to pass two milliliters of blood through a chip with a patented surface coating, designed to mimic the human cell surface membrane. The CTCs then stick to the cell membrane, while non-cancerous cells do not, with the cancerous cells being released into a special tube to enable staining, enumeration and analysis.
Photo: CGToolbox, Getty Images
CORRECTION: An earlier version of this story reported that CellMax Life was raising $15 million in Series C funding, due to a misstated figure in an email communication on behalf of the company. The story has been corrected to report the accurate figure, which is $50 million.